July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and...

22
Investor Presentation ASX:IPD July 2017

Transcript of July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and...

Page 1: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

Investor PresentationASX:IPDJuly 2017

Page 2: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

2

Disclaimer and Forward Looking Statements

DisclaimerThe material contained in this document is a presentation of general information about the activities of ImpediMed Limited (“ImpediMed”) current as at the date of this presentation. The information is provided in a summary form, does not purport to be complete and should not be relied upon as advice for investment purposes. This presentation does not take into account the investment objectives, financial position or needs of any particular investor. Independent advice should be sought before making any investment decision.

SOZO™ is intended only for use in countries in which it has received regulatory approval. Inclusion of products and information does not imply any official medical advice, recommendation or warranty. The information provided is not a substitute for the advice of an appropriate health professional. This website can be accessed from countries around the world and may contain references to products that have not been granted regulatory approval in your country. You should consult your health professional for detailed information regarding ImpediMed’s products and their suitability for you, as well as the regulatory approval status of such products in your country.

To the extent permitted by law, no responsibility for any loss arising in any way (including by way of negligence) from anyone acting or refraining to act as a result of this presentation or its contents is accepted by ImpediMed or any of its officers, employees or agents.

The information in this presentation is subject to change and unless required by law, ImpediMed assumes no obligation to update this presentation or its contents for any matter arising or coming to ImpediMed’s notice after the date of this presentation.

Forward Looking StatementCertain statements in this presentation may constitute forward-looking statements or statements about future matters that are based on management’s current expectations and beliefs. The forward-looking statements in this release include statements regarding the timing of the launch of the next generation product, the ability of the new features to broaden the appeal of the product, and the ability of any new product to meet the needs of the customer base, among others. These statements are subject to risks and uncertainties that are difficult to predict and are based on assumptions as to future events that may not prove accurate. Actual results may differ materially from what is expressed in this presentation.

There can be no assurance that any existing or future regulatory filings will satisfy the relevant authorities’ requirements regarding SOZO™ nor can there be any assurance that SOZO™ will be approved for all applications by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding ImpediMed’s ability to commercialise SOZO™, including its estimates of potential revenues, costs, profitability and financial performance could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; its ability to maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Page 3: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

3

Investment Highlights

• Connected device for precisely measuring and monitoring tissue composition and fluid status using bioimpedance spectroscopy (BIS) technology for early detection and management of chronic disease (e.g. fluid build up in lymphoedema (L-Dex® score), fluid burden for chronic heart failure patients)

• Development complete • Small trials at world leading heart institutions begin Q3 CY2017• FDA 510(k) submission in Q3/Q4 CY2017

• CE Mark achieved June 2017• Broad range of applications both in clinic and at-home• Strong initial enquiry and early sales

• 100+ Leading US cancer centres on board• SOZOTM FDA 510(k) for lymphoedema submitted July 2017• Poised for substantial acceleration of L-Dex® revenues

• Commercial – US, AU and Europe sales expansion• Clinical – various lymphoedema and CHF (internal and 3rd party)• Regulatory – 510(k) clearances for SOZOTM in the US

Strong momentum in US adoption of

L-Dex® for lymphoedema

Chronic Heart Failure (CHF) being readied

for US launch

SOZOTM commercially launched in Australia

and Europe

Significant news flow expected over next

six months

Page 4: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

78%

20%

2%

Institutional Private Founder/Management

• ASX listed (October 2007) • Management Change July 2012• S&P/ASX 300 – added March 2015

Allan Gray 15.0%

Fidelity (FIL) 9.3%

Starfish Ventures 6.8%

Kinetic Investment Partners 5.2%

Paradice Investment Management 5.0%

Substantial Shareholders

Share Register Breakdown

4

Corporate Overview

• Operations in US (San Diego, CA and Bloomington, MN), Australia (Brisbane) and Europe (Greece) (76 staff)

• Market capitalisation ~AU$275M (~375M shares on issue)

• Cash on hand AU$54.9M (30 June 2017)

Page 5: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

5

Bioimpedance Spectroscopy (BIS) Technology

Low Frequency

Current passes around cells

High Frequency

Current passes through cells

256 Frequencies

Unique Spectra

Impe

danc

e

Fluid

Fat

Muscle

Bone

BIS Technology Advantages

• Simple and sophisticated method for measuring fluid and tissue composition

• Rapid, non-invasive

• IPD’s full frequency spectrum (256 frequencies) approach uniquely accurate and specific

• IPD BIS devices used worldwide by major players to measure fluid and body composition in their own various clinical trials (e.g. AstraZeneca, Philips, Kaiser Permanente, University of Alabama, Eiger BioPharmaceuticals)

Page 6: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

6

IPD Legacy BIS Measurement Tool (U400)

• Ground breaking accuracy from 256 frequencies• However: Cumbersome Requires examination room Requires highly trained clinician to administer Patient has to lie down Gel-backed electrodes Testing time: tens of minutes Manual data entry for Electronic Health

Records

SOZOTM – ImpediMed’s State of the Art BIS Tool forChronic Disease Management

SOZOTM – IPD State of the Art BIS Measurement Tool• Equivalent or superior accuracy compared with L-Dex®

U400 and SFB7• Highly sophisticated device that is uniquely simple for

easy patient and clinician use

• Eliminates need for:

An examination room

Gel backed electrodes

Patient to be lying down

A highly trained clinician to administer test

• Reduces testing time from tens of minutes to mere seconds

• Connected device:

Ability to track protocol compliance

Simple expansion with add on software modules for expanded indications

Add on features within modules for increased functionality

Access to de-identified datasets allows for real time analyse to refine algorithms and develop other healthcare uses

Easily integrates with patients’ Electronic Health Records (EHR)

Opens up the large and fast growing at-home patient monitoring market

Page 7: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

Cancer Survivors

Page 8: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

8

Lymphoedema is a leading post-surgical complication for many cancer patients and greatly impacts quality of life. Simple and accurate measurement of fluid in limbs allows early detection and intervention

L-Dex® for the Early Detection of Lymphoedema

1. SOZO™ is not yet approved, cleared or registered for sale in the United States

• If detected early, the progression of lymphoedema can be prevented, and often reversed

• Cancer treatment can damage the lymphatic system and result in fluid build-up in the extremities

• It can become an irreversible, life-long, debilitating condition that progressively gets worse

• L-Dex® detects the onset of lymphoedema very early, ~35 ml of fluid build up versus 200 ml+ for other approaches

• L-Dex®, via SOZO™1, is designed to be used both clinically and by patients at-home

Page 9: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

9

• 100+ major multi-disciplinary cancer centres have incorporated L-Dex®

• Currently using IPD’s FDA cleared U400 device

• Purpose is to integrate L-Dex® testing into clinical work flow practices and systems in preparation for routine use and adoption once SOZOTM

is available

• SOZOTM FDA 510(k) for lymphoedema submitted July 2017

• Poised for sustained acceleration in L-Dex® revenues following SOZOTM

FDA clearance (expected 4Q CY2017)

Immediate SOZOTM device sales Widespread monitoring of cancer patients (reimbursed at US$127

per patient assessment*)

US Commercialisation of L-Dex® Poised forSustained Acceleration

* Requires engagement with local Medicare Administrative Contractors if and when necessary

Page 10: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

10

Two main drivers of Private Payors are:

Global Clinical Trial Data

• IPD’s own 1,100 patient post approval trial Nearly fully enrolled (5 top 50 cancer centres and 3 NCCN institutions are participants in trial) 1st data expected 2H CY2017

• Various independent trials being conducted worldwide E.g. recently reported 6-year, 596-patient trial in Tennessee showing only 3% lymphoedema rates

with L-Dex® (vs. 7%-36% expected without L-Dex®)

Published Industry Guidelines

• NAPBC accreditation requires survivorship care plan

• Lymphoedema introduced into NCCN guidelines in July 2015

• L-Dex® recommended in American Physical Therapy Association Guidelines in July 2017

Introduction of Private Payors will Further Drive Acceleration

1

2

IPD is building a compelling case for Private Payors to initiate coverage in CY2018

Page 11: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

Chronic Heart Failure

Page 12: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

12

• A change of fluid status may signal the need to increase/decrease medication levels

• Correct medication levels significantly reduce hospital stays and readmissions

CHF is a chronic, progressive and debilitating condition

CHF Overview

6.5m+patients

US$31bn+hospitalisation costs alone

Reducing hospital stay and readmission

is a major focus

US government funding bonuses and assessing penalties for physicians

and hospitals that over/under perform

Among the most expensive diseases for the US health care system

Assessing/monitoring fluid status is critical to the management of CHF patients

Page 13: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

13

• Current practice is to monitor CHF patients daily for fluid burden both in clinic and at-home• Current monitoring methods have major shortcomings:

Role of SOZO™ in Optimising Outcomes for CHF Patient Management

Weight Scale • Inaccurate and rudimentary (although low cost – ~US$150 per month)

Implantables • Invasive and expensive – ~US$25,000 (although accurate/precise)

SOZOTM is uniquely positioned to replace current monitoring methods

Precision/accuracy of implantables... ...at the cost of a scale

Page 14: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

14

SOZOTM Regulatory Preparations• CE Mark achieved in June 2017• Submitting for FDA 510(k) clearance for CHF in Q3/Q4 CY2017

Clinical Data for Marketing Purposes• Working with world leading institutions on CHF trials IRB (Ethics) approvals in place for pilot trials Sites trained Sites open for enrolment

Favourable Reimbursement and Guidelines Regime• Reimbursement code established to pay providers to remotely manage patients• Current guidelines in place for daily monitoring of class III patients for fluid burden in US

Commercialisation – EU and US• Initial EU commercial launch to commence Q3/A4 CY 2017• Initial US launch to commence late CY2017 (subject to regulatory clearance / approval)

Heart Failure Program Making Rapid Progress Towards Commercialisation in EU and US

Page 15: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

15

Initial focus on Class III CHF patients• Estimated at 25% of US 6.5 million CHF patients• Monitor and manage the disease progression for

Class III patients

SOZOTM CHF usage model• Baseline reading to be performed in a clinical setting• Daily monitoring to continue in either a clinical or

remote setting

SOZOTM CHF Revenue Model• Initial device purchase plus a per patient per month

subscription model • Well established and growing in CHF market

Expected CHF Business Model

CHF Business Model

Preliminary Estimate of Initial US Addressable Market

Estimated initial patient population ~1.6 million

Preliminary estimated addressable per annum US market based on US$60 per

patient per month over 12 months>US$1.0 billion1

1. Excludes revenue from initial device sales

Page 16: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

16

• Australia Strong initial enquiry, both existing and new customers

• Large Institutional Clients• Physiotherapists • Distributors Cancer focused Medical

Initial units shipped • To select practices and institutions• Installation and training underway

New business model introduced• Multi-year licensing contracts (standard software and updates)• Upgrade pathway for new indications and uses

• Europe Targeted launch

• Initial units shipped• Partnered with master distributor exclusively focused on breast cancer space• Targeting high volume cancer centres in select markets

SOZOTM Approved and Launched in Australia and Europe

Page 17: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

17

L-Dex® adoption and revenue growth• FDA clearance for SOZO™ for lymphoedema – catalyst for significant acceleration in US sales• First data from Vanderbilt PREVENT trial• Private payors to begin coverage of L-Dex® - catalyst for broad adoption in US• Continue building customer base across top tier cancer centres• Expansion into selective markets in Europe and other territories

SOZO™ for heart failure• Initial adoption of SOZOTM in EU and AU• File FDA 510(k) application for SOZO™ for fluid monitoring of heart failure patients• Commercial launch of heart failure in US following FDA clearance• Completion and reporting of pilot trials • Initiation of larger multi-centre marketing trial

Expected News Flow

Page 18: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

Appendix

18

Page 19: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

19

Deep and Broad Commercialisation Experience

Management Team

Frank Vicini, MDChief Medical Officer

• Joined September 2014

• 25+ years as radiation oncologist

• Completed his fellowship at Harvard Medical School, has authored over 200 peer reviewed publications, and participated in 6 NIH clinical trials and the MammoSiteRegistry trial

Morten VigelandChief Financial Officer

• Joined April 2011• 15+ years in financial

management in the medical technology industry

• Experience in med-tech start-ups and emerging growth companies

Catherine KingsfordSVP Medical Affairs

• Joined January 2007• 20+ years global

clinical experience with medical devices

• Previously worked as a cardiac scientist at several world-class medical institutions including St. Andrew's War Memorial Hospital, The Prince Charles Hospital, and Royal Brompton Hospital

Dennis SchlahtSVP Quality, R&Dand Technology

• Joined October 2007• 30+ years in

engineering development and product marketing

• Previously Vice President of Marketing and Product Development at XiTRON’s Test and Measurement Business

David AdamsSVP Ventures, Licensing & Corporate Development

• On Board November 2013 to August 2016

• Joined August 2016• Background as medical

device investment & business development executive

• 25+ years experience in tax, financial planning, and business development

• Previously Vice President, Integrations and Divestitures at Medtronic

Richard CarreonManaging Director andChief Executive Officer

• Joined July 2012• 30+ years

experience• Extensive

experience in the medical device field and growth companies

• Previously Vice President at Medtronic (10 years)

Page 20: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

20

Board of Directors

Gary GoetzkeJuris DoctorateNon-Executive Director

• Joined August 2016• 15+ years in senior

management positions with medical device companies

• Currently the Principle and Chief Executive Officer of Compass Medical Advisors, LLC

Scott R. WardMS, BScNon-Executive Director

• Joined July 2013• Venture capitalist with

30+ years experience in healthcare industry

• Previously Senior Vice President and President of the Cardiovascular business of Medtronic

• Chairman of the Board of Creganna-Tactx Medical Devices and Cardiovascular Systems, Inc.

Donald A. WilliamsBAcy, CPANon-Executive Director

• Joined March 2017• 35+ years in

leadership roles serving the life science, biotech, and medical device industries

• Currently the Audit Committee Chair of Akari Therapeutics, Alphatec Holdings, Marina Biotech, and Proove Biosciences, and the Compensation Committee for Marina Biotech

Amit R. PatelMBA, BMENon-Executive Director

• Joined March 2017• 8+ years in senior

management positions

• Currently the board of Vios Medical and Pillsbury United Communities

• Currently the CEO and Co-Founder of Vios Medical

Richard CarreonManaging Director andChief Executive Officer

• See previous slide

Cherrell Hirst AOFTSE, MBBS, BEdSt, D.Univ (Hon), FAICD

Non-Executive Chairman

• On Board since 2005 • Appointed Non-

Executive Chairman in Nov 2011

• Leading medical practitioner in breast cancer screening/diagnosis

• Currently Chairman of Tissue Therapies Ltd and Non-Executive Director of Medibank Private Ltd

Judith DownesNon-Executive Director

• Joined April 2017• 20+ years of

accounting and senior management expertise with large ASX listed companies

• Previously a CFO at Alumina Limited and CFO/COO of Institutional Division, ANZ Banking Group Limited

• Currently Board Chairman of Bank Australia Limited and Honorary Fellow of the University of Melbourne’s Faculty of business and Economics

Page 21: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

21

US Advisory Board Members and Clinical Research Team

European Advisory Board Members

World Renowned Medical Advisory Boardfrom Leading US CHF Institutions

Marco Metra, MD • Professor of Cardiology at

University of Brescia, Italy

Professor GerasimosFilippatos, MD, FESC, FACC• Head of the Heart Failure

Unit at Athens University Hospital Attikon, Greece.

• Current President of European Society of Cardiology - Heart Failure (ESC-HF)

Professor Piotr Ponikowski, MD, PhD • Head of Cardiology

Department, Medical University Wroclaw Poland

Professor Stefan Anker, MD, PhD • Professor of Innovative

Clinical Trials at U Medical Center Gottingen, Germany

Roy Small, MD FACC, FSCAI • Medical Director of Clinical

Research, Lancaster General Hospital

Paul Friedman, MD• Vice Chair, Department of

Cardiovascular Medicine• Medical Director, Remote

Monitoring, Mayo Clinic

Andrew Accardi, MD • Chairman of Emergency

Medicine, Scripps Memorial Hospital Encinitas

J. Thomas Heywood, MD • Director, Heart Failure

Recovery and Research Program, Scripps Health

Laura Mauri, MD, MSc• Chief Scientific Advisor,

Harvard Clinical Research Institute; Recognised leader in the use of statistical methods in clinical

Page 22: July 2017 Investor Deck v10 FINAL › AsxDownload.aspx?pdfUrl=Report...government, industry, and general public pricing pressures; and additional factors that involve significant risks

Oncology Revenue (000’s) Cash Balance (000’s) Market Cap (millions)

For the Twelve Months Ended 30 June 2017 (Unaudited and Preliminary)

22

Financials YTD